FDA-Drug2022-06-01Class II

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3

Noven Pharmaceuticals Inc
Hazard

Defective Delivery System: customer complaints exceeded respective action limits.

Sold states
Nationwide to the U.S. Market
Affected count
274, 110 patches
Manufactured in
11960 Sw 144th St, Miami, FL, United States
Products
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0889-2022

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